Last reviewed · How we verify
NCT00782184
A Randomized, Double-Blind, Active-Controlled Study of Patients With Primary Hypercholesterolemia and High Cardiovascular Risk and Not Adequately Controlled With Atorvastatin: A Comparison of Switching to a Combination Tablet Ezetimibe/Simvastatin Versus Doubling the Baseline Dose of Atorvastatin
Phase 3 trial testing ezetimibe/simvastatin 10/40 in Hypercholesterolemia in 250 participants. Completed in 1 September 2010.
1 September 2010
Quick facts
| Lead sponsor | Organon and Co |
|---|---|
| Phase | Phase 3 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | double |
| Primary purpose | treatment |
| Enrollment | 250 |
| Start date | 1 November 2008 |
| Primary completion | 1 September 2010 |
| Estimated completion | 1 September 2010 |
Drugs / interventions tested
- ezetimibe/simvastatin 10/40 — full drug profile →
- atorvastatin 40 mg — full drug profile →
- atorvastatin 20 mg
Conditions studied
- Hypercholesterolemia — all drugs for Hypercholesterolemia →
Sponsor
Organon and Co — full company profile →
Who can join
Adults 18 to 79, any sex, with Hypercholesterolemia. Patients with the condition only — healthy volunteers not accepted.
What's being measured
Primary outcomes are the specific endpoints the trial is designed to prove or disprove.
-
Percent Change From Baseline in Low Density Lipoprotein (LDL)-C
Time frame: Baseline (Treatment Day 1), Treatment Week 6
Sponsor's own description
Participants currently taking atorvastatin 20 mg will be switched to either atorvastatin 40 mg or ezetimibe/simvastatin 10 mg/40 mg (10/40). After 6 weeks of treatment, the percent reduction in low-density lipoprotein cholesterol (LDL-C) will be assessed and compared between the two treatment groups.
Publications & conference data
1 peer-reviewed publication reference this trial (live from Europe PMC):
-
Ezetimibe/simvastatin 10/40 mg versus atorvastatin 40 mg in high cardiovascular risk patients with primary hypercholesterolemia: a randomized, double-blind, active-controlled, multicenter study.
Hing Ling PK, Civeira F, Dan AG, Hanson ME, et al · · 2012 · cited 9× · PMID 22293030 · DOI 10.1186/1476-511x-11-18
Verify or expand the search:
- PubMed search for NCT00782184
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other recruiting trials for Hypercholesterolemia
Currently open trials in the same condition.
- NCT07406191 — WB-EMS Effects on Cardiometabolic Risk Factors · NA · recruiting
- NCT07374861 — Multicenter Study on the Evaluation of Adherence, Persistence and Efficacy of Treatment With Bempedoic Acid in Italy · recruiting
- NCT07295327 — Effect of Two Food Supplements on Lipid Profile in Patients With Mild Hypercholesterolemia · NA · recruiting
- NCT06568601 — Pharmacogenomic Informed Statin Prescribing · NA · recruiting
- NCT06423365 — A Tool to Help Patients With Muscle Symptoms After Taking a Statin Medication. · NA · active not recruiting
Other Organon and Co trials
Trials by the same sponsor.
- NCT05761444 — Effectiveness and Safety Study of Early add-on of Ezetimibe With Atorvastatin in Very High-risk Patients · Phase 4 · completed
- NCT05789576 — A Study to Investigate Efficacy and Safety of VTAMA® (Tapinarof) Cream, 1% in Plaque Psoriasis in the Head and Neck Regi · Phase 4 · completed
- NCT05680740 — A Study to Investigate Efficacy and Safety of VTAMA (Tapinarof) Cream, 1% in Intertriginous Plaque Psoriasis · Phase 4 · completed
- NCT05560646 — A Study to Investigate Efficacy and Safety of OG-6219 BID in 3 Dose Levels Compared With Placebo in Participants Aged 18 · Phase 2 · completed
- NCT05264506 — Contraceptive Efficacy and Safety of NOMAC-E2 Combined Oral Contraceptive · Phase 3 · terminated
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT00782184 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Organon and Co
- Last refreshed: 8 May 2024
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT00782184.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing